Spinal implant system and method

ABSTRACT

A spinal implant comprises a body including an inner surface that defines a cavity configured for disposal of a member. A locking element is engageable with the member within the cavity to fix the member with the body. The body further includes a wall that defines a bay configured for disposal of a longitudinal element being engageable with the wall to fix the longitudinal element with the body independent of the member. Systems and methods are disclosed.

TECHNICAL HELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to asurgical system and method for correction of a spine disorder.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor, and fracture mayresult from factors including trauma, disease and degenerativeconditions caused by injury and aging. Spinal disorders typically resultin symptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. Correction treatments used for positioning andalignment may employ implants, such as vertebral rods, bone screws andsub-laminar wire, for stabilization of a treated section of a spine.This disclosure describes an improvement over these prior technologies.

SUMMARY

In one embodiment, a spinal implant comprises a body including an innersurface that defines a cavity configured for disposal of a member. Alocking element is engageable with the member within the cavity to fixthe member with the body. The body further includes a wall that definesa bay configured for disposal of a longitudinal element being engageablewith the wall to fix the longitudinal element with the body independentof the member. In some embodiments, systems and methods are disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of one embodiment of components of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a side view of the components shown in FIG. 1;

FIG. 3 is a side view of the components shown in FIG. 1;

FIG. 4 is a side view of the components shown in FIG. 1;

FIG. 5 is an end view of the components shown in FIG. 1;

FIG. 6 is an end view of the components shown in FIG. 1;

FIG. 7 is a cross section view of one embodiment of components of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 8 is a side view of one embodiment of components of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 9 is a cross section view of the components shown in FIG. 8:

FIG. 10 is a side view of one embodiment of components of a surgicalsystem in accordance with the principles of the present disclosure; and

FIG. 11 is a perspective view of one embodiment of components of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae.

DETAILED DESCRIPTION

The exemplary embodiments of a surgical system and related methods ofuse are discussed in terms of medical devices for the treatment ofmusculoskeletal disorders and more particularly, in terms of a surgicalsystem and method for correction of a spine disorder. In someembodiments, the surgical system may be employed in applications forcorrection of deformities, such as scoliosis and kyphosis.

In some embodiments, the surgical system includes a spinal implantincluding a tether connector. In some embodiments, the surgical systemincludes a spinal implant including a tether connector configured to fixa posterior spinal rod to a spine by a tether such that the spinal rodis fixed in a flexible and/or dynamic configuration. In someembodiments, the tether connector is fixed with a spine at a top levelof a spinal construct. In some embodiments, the tether connector isfixed with a spine at one or a plurality of levels of a spinalconstruct. In some embodiments, the tether connector is fixed to aspinal rod and maintains a tether in place after the tether is wrappedabout vertebral tissue, such as, for example, a lamina. In someembodiments, the tether connector includes one or a plurality ofcoupling members, such as, for example, set screws. In some embodiments,the tether connector includes a set screw that engages a spinal rod anda set screw that facilitates locking of a tether.

In some embodiments, the tether connector includes one or a plurality ofcoupling members, such as, for example, set screws that attach asub-laminar tether to a spinal rod. In some embodiments, the tetherconnector includes two set screws that allow for locking of a spinal rodand a tether separately. In some embodiments, the tether connectorprovides separate manipulation of the spinal rod and the tether duringsurgery. In some embodiments, the tether connector includes a set screwthat facilitates locking of a tether, the set screw including a lockingportion, such as, for example, a break off element and a revisionportion. In some embodiments, the break off element is offset from therevision portion.

In some embodiments, the tether connector includes a lock, such as, forexample, a locking cleat that facilitates attachment of a sub-laminartether to a spinal rod. In some embodiments, the locking cleat includesfixation elements, such as, for example, teeth that maximize the surfacearea holding the tether with the teeth. In some embodiments, the lockingcleat includes teeth that maximize line to line pressure and increasefrictional engagement with the tether. In some embodiments, the lockingcleat includes teeth having a serpentine configuration and/or define aserpentine path therebetween to increase frictional engagement with thetether. In some embodiments, the set screw connected with the lockingcleat has a break off element to provide a positive indicator that thetether connector is selectively secured with vertebral tissue. In someembodiments, the tether connector includes a locking cleat connectedwith a set screw such that the screw is rotated to translate the cleat.In some embodiments, the cleat is translated to define a pathway of thetether connector for disposal of a tether. In some embodiments, thecleat is translated between a first position relative to the tetherconnector to define a pathway of the tether connector for disposal of atether and a second position relative to the tether connector such thatthe cleat is clamped to the tether to fix the tether with the tetherconnector. In some embodiments, the cleat is connected with the setscrew via a pin.

In some embodiments, the tether connector includes a threaded openingfor disposal of a set screw engageable with a spinal rod, a break offtether locking set screw, a surface defining a spinal rod slot, a tetherlocking cleat and a surface defining surgical instrument attachmentslots. In some embodiments, the tether connector has a minimizedprofile. In some embodiments, the tether connector has a 9 millimeter(mm) profile and/or run along a spinal rod.

In some embodiments, the surgical system is used with surgicalnavigation, such as, for example, fluoroscope or image guidance. In someembodiments, one or all of the components of the surgical system aredisposable, peel-pack, pre-packed sterile devices. One or all of thecomponents of the surgical system may be reusable. The surgical systemmay be configured as a kit with multiple sized and configuredcomponents.

In some embodiments, the present disclosure may be employed to treatspinal disorders such as, for example, degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor and fractures. In someembodiments, the present disclosure may be employed with other ostealand bone related applications, including those associated withdiagnostics and therapeutics. In some embodiments, the disclosedsurgical system and methods may be alternatively employed in a surgicaltreatment with a patient in a prone, supine position, lateral and/oremploy various surgical approaches to the spine, including anterior,posterior, posterior mid-line, direct lateral, postero-lateral, and/orantero-lateral approaches, and in other body regions. The presentdisclosure may also be alternatively employed with procedures fortreating the lumbar, cervical, thoracic, sacral and pelvic regions of aspinal column. The system and methods of the present disclosure may alsobe used on animals, bone models and other non-living substrates, suchas, for example, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the embodiments taken inconnection with the accompanying drawing figures, which form a part ofthis disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. In some embodiments, as used inthe specification and including the appended claims, the singular forms“a,” “an”, and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, micro discectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. As used in the specification andincluding the appended claims, the term “tissue” includes soft tissue,ligaments, tendons, cartilage and/or bone unless specifically referredto otherwise.

The following discussion includes a description of a surgical system andrelated methods of employing the surgical system in accordance with theprinciples of the present disclosure. Alternate embodiments are alsodisclosed. Reference is made in detail to exemplary embodiments of thepresent disclosure, which are illustrated in the accompanying figures.Turning to FIGS. 1-6, there are illustrated components of a surgicalsystem, such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,stainless steel alloys, superelastic metallic alloys (e.g., Nitinol,super elasto-plastic metals, such as GUM METAL®), ceramics andcomposites thereof such as calcium phosphate (e.g., SKELITE™),thermoplastics such as polyaryletherketone (PAEK) includingpolyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate such as hydroxyapatite (HA), corraline HA, biphasiccalcium phosphate, tricalcium phosphate, or fluorapatite, tri-calciumphosphate (TOP), HA-TOP, calcium sulfate, or other resorbable polymerssuch as polypeptide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations, biocompatible ceramics,mineralized collagen, bioactive glasses, porous metals, bone particles,bone fibers, morselized bone chips, bone morphogenetic proteins (BMP),such as BMP-2, BMP-4, BMP-7, rhBMP-2, or rhBMP-7, demineralized bonematrix (DBM), transforming growth factors (TGF, e.g., TGF-β), osteoblastcells, growth and differentiation factor (GDF), insulin-like growthfactor 1, platelet-derived growth factor, fibroblast growth factor, orany combination thereof.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 comprises a spinal implant, such as, for,example, a connector 12. Connector 12 includes a body 14 having asurface 16 that defines a cavity 18 configured for disposal of a member,such as, for example, a tether 20, as described herein. Cavity 18 isconfigured for movable disposal of a locking element 22 configured tofix tether 20 with body 14 between a non-locking orientation, such as,for example, as shown in FIG. 7, and a locked orientation, such as, forexample, as shown in FIG. 9 and described herein. In some embodiments,cavity 18 may have various cross section configurations, such as, forexample, oval, oblong, triangular, rectangular, square, polygonal,irregular, uniform, non-uniform, variable and/or tapered. In someembodiments, surface 16 may include gripping elements or surfaces, suchas, for example, rough, arcuate, undulating, mesh, porous, semi-porous,dimpled and/or textured to facilitate engagement with tether 20.

Surface 16 defines a slot 24 configured for engagement with a portion oflocking element 22, as described herein. Slot 24 includes a proximal end26 having a surface 28 and a distal end 30 having a surface 32. Ends 26,30 define a range of translation of locking element 22 as lockingelement 22 translates within cavity 18 between a non-locking orientationand a locked orientation.

Surface 16 defines a channel 34 in communication with cavity 18. Channel34 is configured for disposal of tether 20. In some embodiments, channel34 includes a linear portion 36 and a transverse portion 38. Tether 20is configured for disposal with channel 34 between a movableconfiguration and a fixed configuration, as described herein. Transverseportion 38 defines an engagement surface and/or a lock surface such thattether 20 is fixed with transverse portion 38 via compressive forcesand/or friction forces, applied at least in the direction shown by arrowA in FIG. 9, by locking element 22, as described herein. In someembodiments, the compressive forces applied by locking element 22, totether 20, and/or to transverse portion 38 may be directed in variousorientations, such as, for example, perpendicular, transverse and/or atangular orientations, such as acute or obtuse.

Locking element 22 includes a screw 40 and a fixation element, such as,for example, a cleat 42. Screw 40 includes a portion 44 and a portion46. Portions 44, 46 are connected at a reduced diameter portion 48 thatis tangibly connected to portion 46. In some embodiments, portion 46 isconfigured for a threaded engagement with surface 16. In someembodiments, portions 44, 46 are fabricated from a fracturing and/orfrangible material such that manipulation of portion 44 relative toportion 46 can fracture and separate portion 44 from portion 46 at apredetermined force and/or torque limit, as described herein. In someembodiments, as force and/or torque is applied to portion 44 andresistance increases, for example, due to fixation of portion 44 withcavity 18, as described herein, the predetermined torque and force limitis approached. In some embodiments, portions 44, 46 include offset hexgeometries.

In some embodiments, portions 44, 46 can fracture and separate at apredetermined force or torque limit, which may be in a range ofapproximately 20 Newton centimeters (N-cm) to 50 N-cm. In someembodiments, portions 44, 46 may have the same or alternate crosssection configurations, may be fabricated from a homogenous material orheterogeneously fabricated from different materials, and/or alternatelyformed of a material having a greater degree, characteristic orattribute of plastic deformability, frangible property and/or break awayquality to facilitate fracture and separation of portions 44, 46.

Portion 46 includes a shaft 50 having an outer surface 52. Surface 52includes a thread form 54 configured for engagement with surface 16. Insome embodiments, thread form 54 is continuous along surface 52. In someembodiments, thread form 54 may include a single thread turn or aplurality of discrete threads. In some embodiments, other penetratingelements may be located on shaft 50, such as, for example, a nailconfiguration, barbs, expanding elements, raised elements, ribs, and/orspikes to facilitate engagement of shaft 50.

Cleat 42 includes a surface 60 that defines a cavity 62. Cavity 62 isconfigured for disposal of screw 40. Screw 40 is connected with cleat 42by retention pin 64, as shown in FIG. 7. Retention pin 64 allow forrotation of screw 40 relative to cleat 42 to facilitate translation ofcleat 42 into contact with tether 20 to engage and disengage cleat 42with tether 20.

Cleat 42 includes a surface 66 oriented to engage tether 20 and/ortransverse portion 38. Surface 66 is angled such that surface 66 isconfigured for alignment with transverse portion 38 to facilitateengagement of tether 20 in a locked orientation, as described herein. Insome embodiments, surface 66 may include penetrating members, such as,for example, a plurality of teeth 68. In some embodiments, teeth 68 mayhave various configurations, for example, round, oval, rectangular,polygonal, irregular, tapered, offset, staggered, uniform andnon-uniform. Cleat 42 is engageable with screw 40 such that as screw 40is actuated, cleat 42 includes a range of translation within cavity 18and slot 24 to facilitate engagement and/or disengagement withtransverse portion 38 and/or tether 20 in a non-fixed and/or non-lockingorientation with body 14 and a fixed and/or locked orientation with body14. In the locked orientation, teeth 68 engage transverse portion 38and/or tether 20 to fix tether 20 with body 14. Surface 66 engagestransverse portion 38 to apply a compressive force and/or a frictionforce, as described herein, to fix tether 20 in a locked orientation.

Cleat 42 includes a surface 70. Surface 70 includes a protrusion, suchas, for example, a flange 72. Flange 72 is configured for engagementwith the surface that defines slot 24. Flange 72 slidably translatesalong slot 24 between ends 26, 30. Ends 26, 30 define a range oftranslation of flange 72 as flange 72 translates within slot 24. In someembodiments, flange 72 engages surface 28, which comprises a proximalstop corresponding to a translation limit for a non-locking orientationof locking element 22, as shown in FIG. 7. In some embodiments, flange72 engages surface 32, which comprises a distal stop corresponding to atranslation limit for a locking orientation of locking element 22, asshown in FIG. 9. Surfaces 28, 32 are configured to resist and/or preventtranslation of flange 72 beyond a selected limit.

Body 14 includes a wall 80 having a surface 82. Wall 80 includesextensions 84 a, 84 b. Extensions 84 a, 84 b define an opening, such as,for example, a bay 86 configured for disposal of a longitudinal element,such as, for example, a spinal rod 88 (FIG. 11). In some embodiments,cavity 18 is disposed separate and apart from bay 86. In someembodiments, cavity 18 is disposed transverse to bay 86. In someembodiments, cavity 18 may be disposed in various orientations, such as,for example, perpendicular, transverse and/or at angular orientations,such as acute or obtuse relative to bay 86. In some embodiments, cavity18 may be disposed offset or staggered from bay 86. In some embodiments,bay 86 may have various cross section configurations, such as, forexample, oval, oblong, triangular, rectangular, square, polygonal,irregular, uniform, non-uniform, variable and/or tapered. In someembodiments, surface 82 may include gripping elements or surfaces, suchas, for example, rough, arcuate, undulating, mesh, porous, semi-porous,dimpled and/or textured to facilitate engagement with spinal rod 88.

Body 14 includes a surface 90 that defines a cavity, such as, forexample, an opening 92. Surface 90 is threaded and configured fordisposal of a coupling member, such as, for example, a set screw 94. Insome embodiments, set screw 94 includes an end having a hexagonalgeometry configured for engagement with a similarly shaped surgicaltool, such as, for example, a driver. In some embodiments, set screw 94includes an end having a cruciform, phillips, square, hexalobe,polygonal or star cross sectional configuration for disposal of acorrespondingly shaped portion of a driver. Set screw 94 is configuredfor engagement with spinal rod 88 to facilitate fixation and/or lockingof spinal rod 88 with body 14.

Set screw 94 is disposable between a non-locking orientation, such thatspinal rod 88 is translatable relative to body 14 and a lockedorientation, such that set screw 94 fixes spinal rod 88 with body 14. Insome embodiments, set screw 94 includes a portion 102 and a portion 104.Portions 102, 104 are connected at a reduced diameter portion 106 thatis frangibly connected to portion 104. In some embodiments, portions102, 104 are fabricated from a fracturing and/or frangible material suchthat manipulation of portion 102 relative to portion 104 can fractureand separate portion 102 from portion 104 at a predetermined forceand/or torque limit, as described herein.

In some embodiments, body 14 includes a mating surface 110 that definescavities, such as, for example, mating capture elements 112 configuredto mate with a surgical instrument to facilitate implant andmanipulation of connector 12 and/or components of spinal implant system10. In some embodiments, spinal implant system 10 may include one or aplurality of connectors 12 spaced apart and disposed along spinal rod88, which may be relatively disposed in a side by side, irregular,uniform, non-uniform, offset and/or staggered orientation orarrangement, along one or a plurality of spinal rods 88. In someembodiments, spinal rod 88 extends along one or a plurality of vertebra,as described herein. In some embodiments, spinal implant system 10 mayinclude one or a plurality of spinal rods 88, which may be relativelydisposed in a side by side, irregular, uniform, non-uniform, offsetand/or staggered orientation or arrangement.

Tether 20 extends between an end 116 and an end 118, as shown in FIG.10. Tether 20 is configured for engagement with connector 12, asdescribed herein. In some embodiments, end 116 and end 118 form a loop120 configured to surround all or a portion of tissue, such as, forexample, laminae and/or spinal rod 88, as described herein. Tether 20 isconfigured for tensioning about a targeted portion of an anatomy of abody for attachment of tether 20 with the targeted portion of theanatomy, as described herein. In some embodiments, the targeted portionof the anatomy may include laminae, transverse process and/or pedicleregions of a vertebral level. In some embodiments, spinal implant system10 may include one or a plurality of tethers 20, each tether 20 beingconfigured for disposal about a single and separate vertebral level. Insome embodiments, a single vertebral level may include one or aplurality of tethers 20.

Tether 20 has a flexible configuration and may be fabricated frommaterials, such as, for example, fabric, silicone, polyurethane,silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers andelastomeric composites. In some embodiments, the flexibility of tether20 includes movement in a lateral or side to side direction and preventsexpanding and/or extension in an axial direction upon tensioning andattachment with a targeted portion of the anatomy. In some embodiments,all or only a portion of tether 20 may have a semi-rigid, rigid orelastic configuration, and/or have elastic properties, similar to thematerial examples described herein, such that tether 20 provides aselective amount of expansion and/or extension in an axial direction. Insome embodiments, tether 20 may be compressible in an axial direction.Tether 20 can include a plurality of separately attachable orconnectable portions or sections, such as bands or loops, or may bemonolithically formed as a single continuous element.

Tether 20 can have a uniform thickness/diameter. In some embodiments,tether 20 may have various surface configurations, such as, for example,smooth and/or surface configurations to enhance fixation, such as, forexample, rough, arcuate, undulating, porous, semi-porous, dimpled,polished and/or textured. In some embodiments, the thickness defined bytether 20 may be uniformly increasing or decreasing, or have alternatediameter dimensions along its length. In some embodiments, tether 20 mayhave various cross section configurations, such as, for example, oval,oblong, triangular, rectangular, square, polygonal, irregular, uniform,non-uniform, variable and/or tapered. In some embodiments, the surfaceof tether 20 may include engaging structures, such as, for example,barbs, raised elements and/or spikes to facilitate engagement withtissue of the targeted anatomy.

In some embodiments, the surface of tether 20 may include a pliablelead. In some embodiments, tether 20 may include a pliable lead suchthat tether 20 can be passed and/or guided through cavities of spinaltissue to resist and/or prevent non-desirable and/or harmful engagementwith selected and/or sensitive anatomy of the spinal tissue. In someembodiments, the pliable lead is soft and flexible and configured topass through a sub-laminar cavity of vertebrae without adhering to duramatter of a spinal cord and/or surfaces of a lamina of a vertebrallevel. In some embodiments, all or only a portion of the pliable lead isfabricated from a pliable, low-friction material, such as, for example,silicone, polyurethane, silicone-polyurethane copolymers, polymericrubbers, polyolefin rubbers, elastomers, rubbers, thermoplasticelastomers, thermoset elastomers and elastomeric composites.

In some embodiments, tether 20 may have various lengths. In someembodiments, tether 20 may be braided, such as a rope, or include aplurality of elongated elements to provide a predetermined forceresistance. In some embodiments, tether 20 may be made from autograftand/or allograft, and be configured for resorbable or degradableapplications. In one embodiment, tether 20 is a cadaver tendon. In oneembodiment, tether 20 is a tendon that may be harvested, for example,from a patient or donor. In some embodiments, a tendon harvested from apatient may be affixed in remote locations with the patient's body.

In assembly, operation and use, spinal implant system 10, similar to thesystems and methods described herein, is employed with a surgicalprocedure, such as, for example, a correction treatment of an affectedportion of a spine, for example, a correction treatment to treatadolescent idiopathic scoliosis and/or Scheuermann's kyphosis of aspine. In some embodiments, one or all of the components of spinalimplant system 10 can be delivered or implanted as a pre-assembleddevice or can be assembled in situ. Spinal implant system 10 may becompletely or partially revised, removed or replaced.

In use, to treat a selected section of vertebrae V, including vertebraeV1, V2, as shown in FIG. 11, a medical practitioner obtains access to asurgical site including vertebrae V in any appropriate manner, such asthrough incision and retraction of tissues. In some embodiments, spinalimplant system 10 can be used in any existing surgical method ortechnique including open surgery, mini-open surgery, minimally invasivesurgery and percutaneous surgical implantation, whereby vertebrae V isaccessed through a mini-incision, or a sleeve that provides a protectedpassageway to the area. Once access to the surgical site is obtained,the particular surgical procedure can be performed for treating thespine disorder.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway for implantation of components ofspinal implant system 10. A preparation instrument (not shown) can beemployed to prepare tissue surfaces of vertebrae V, as well as foraspiration and irrigation of a surgical region.

Tether 20 is delivered along the surgical pathway to a surgical siteadjacent vertebrae V. End 116 of tether 20 is guided through channel 34for attachment with connector 12, as described herein. Tether 20 isdisposed with vertebrae V and threaded with channel 34, as describedherein, to capture selected spinal tissue of vertebrae V, for example,tether 20 is wrapped about tissue of vertebra V1 and/or vertebra V2.

Screw 40 is rotated in a counter clockwise direction, as shown by arrowB in FIG. 11, to dispose in a non-locked orientation, as shown in FIG.7, such that tether 20 is movable within channel 34 and cleat 42 ispositioned such that flange 72 is engaged with surface 28. End 118 isinserted into channel 34 to form loop 120 about tissue of vertebra V1and/or vertebra V2. In one embodiment, loop 120 is disposed about atransverse process of vertebra V2 by passing end 118 continuously aboutthe transverse process. Loop 120 is fixed and/or attached with thetransverse process and/or lamina. Tether 20 is threaded through channel34.

A surgical instrument, such as, for example, a tensioner T is disposedadjacent connector 12. Tensioner T is aligned and engaged with matingcapture elements 112 for releasable fixation and/or provisional fixationof tensioner T with connector 12. Tensioner T is actuated to tensiontether 20 about vertebra V2. In some embodiments, the tension and/ortensile force applied to tether 20 and/or corrective forces applied tovertebrae V can be increased and/or decreased by tensioner T.

Screw 40 is actuated by a driver (not shown) by rotating screw 40 in aclockwise direction to engage cleat 42. Cleat 42 is translated withincavity 18, as shown by arrow C in FIG. 9. Translation of cleat 42 causessurface 66 and teeth 68 to engage tether 20 and/or transverse portion38. Translation of cleat 42 causes flange 72 to approach and/or engagesurface 32 of end 30 to dispose locking element 22 in a lockedorientation with body 14. Surface 66 applies a compressive force and/ora friction force to the lock surface of transverse portion 38, as shownby arrow A in FIG. 9, to fix tether 20 in a locked orientation with body14.

The driver is rotated in a clockwise direction, as shown by arrow D inFIG. 11, to a predetermined force and/or torque limit, to cause portions44, 46 to separate, as described herein. This configuration fixestension of tether 20 about vertebra V2 and tensions components of thespinal construct for attachment with vertebrae V and/or to applycorrective treatment to vertebrae V.

Spinal rod 88 is disposed with bay 86. Set screw 94 is engaged withopening 92. Set screw 94 is engaged with a surgical instrument, such as,for example, a driver (not shown), which advances set screw 94 intoopening 92 in a non-locking orientation, as described herein. Spinal rod88 is translatable relative to body 14. The driver engages set screw 94to fix spinal rod 88 with body 14 and for attachment of spinal rod 88with vertebrae V via tether 20.

In some embodiments, spinal implant system 10 includes a second spinalrod 88 (not shown) delivered along the surgical pathway to the surgicalsite adjacent a contra-lateral side of vertebrae V. Second spinal rod 88is connected with the contra-lateral side of vertebrae V via one or moretethers 20, similar to spinal rod 88 described herein. In someembodiments, spinal rod 88 and second spinal rod 88 are fixed withvertebrae V in a side by side orientation and/or a bilateral arrangementto stabilize vertebrae V and affect growth for a correction treatment totreat spine pathologies, as described herein. In some embodiments, oneor all of the components of spinal implant system 10 can be delivered orimplanted as a pre-assembled device or can be assembled in situ, in aselected order of assembly or the order of assembly of the particularcomponents of system 10 can be varied according to practitionerpreference, patient anatomy or surgical procedure parameters. Spinalimplant system 10 may be completely or partially revised, removed orreplaced.

Upon completion of the procedure, the surgical instruments, assembliesand non-implanted components of spinal implant system 10 are removedfrom the surgical site and the incision is closed. One or more of thecomponents of spinal implant system 10 can be made of radiolucentmaterials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.In some embodiments, the use of surgical navigation, microsurgical andimage guided technologies may be employed to access, view and repairspinal deterioration or damage, with the aid of spinal implant system10.

In some embodiments, spinal implant system 10 includes an agent, whichmay be disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of spinal implant system 10. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft to enhance fixation of the bone fastenerswith vertebrae. In some embodiments, the agent may include one or aplurality of therapeutic agents and/or pharmacological agents forrelease, including sustained release, to treat, for example, pain,inflammation and degeneration.

In some embodiments, the components of spinal implant system 10 may beemployed to treat progressive idiopathic scoliosis with or withoutsagittal deformity in either infantile or juvenile patients, includingbut not limited to prepubescent children, adolescents from 10-12 yearsold with continued growth potential, and/or older children whose growthspurt is late or who otherwise retain growth potential. In someembodiments, the components of spinal implant system 10 may be used toprevent or minimize curve progression in individuals of various ages.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1-20. (canceled)
 21. A spinal implant comprising: a body includingopposite first and second surfaces and opposite top and bottom surfacesthat each extend from the first surface to the second surface, the bodyincluding an inner surface that defines a passageway that extendsthrough the top and bottom surfaces, the body further including a baythat extends into the first surface; and a locking element comprising ascrew and a fixation element, the screw being positioned within thepassageway and including a shank that defines a longitudinal axis, thefixation element being coupled to the screw such that the fixationelement is rotatable relative to the screw about an axis that extendstransverse to the longitudinal axis.
 22. A spinal implant as recited inclaim 21, wherein the inner surface includes a threaded portion, thescrew comprising a thread that directly engages the threaded portion.23. A spinal implant as recited in claim 21, wherein the fixationelement is coupled to the screw by a pin.
 24. A spinal implant asrecited in claim 21, wherein the bay is positioned between the topsurface and the bottom surface.
 25. A spinal implant as recited in claim21, wherein the body includes a channel that extends through the top andbottom surfaces, the channel comprising a first portion that is incommunication with the passageway and a second section that is spacedapart from the passageway by a wall that defines a threaded portion ofthe inner surface.
 26. A spinal implant as recited in claim 25, whereinthe screw comprises a thread that directly engages the threaded portion.27. A spinal implant as recited in claim 25, wherein the body includes asecond inner surface that defines a portion of the channel, the secondinner surface including a portion that extends transverse to thelongitudinal axis and is configured for engagement with the fixationelement.
 28. A spinal implant as recited in claim 21, wherein the bodyincludes an opening that extends through the top surface, the openingbeing in communication with the bay.
 29. A spinal implant as recited inclaim 28, wherein the opening extends transverse to the longitudinalaxis.
 30. A spinal implant as recited in claim 28, wherein the openingis threaded.
 31. A spinal implant as recited in claim 21, wherein thebottom surface is permanently fixed relative to the top surface.
 32. Aspinal implant as recited in claim 21, wherein the inner surface furtherdefines a slot having a proximal end and a distal end, the fixationelement being engageable with the inner surface adjacent to the ends todefine a range of translation of the locking element within the cavity.33. A spinal implant as recited in claim 32, wherein the fixationelement includes an outer flange that is engageable with the innersurface adjacent to the ends.
 34. A spinal implant comprising: a bodyincluding opposite first and second surfaces and opposite top and bottomsurfaces that each extend from the first surface to the second surface,the bottom surface being permanently fixed relative to the top surface,the body including an inner surface that defines a passageway thatextends through the top and bottom surfaces, the body further includinga bay that extends into the first surface, the bay being spaced apartfrom the passageway by the inner surface; and a locking elementcomprising a screw and a fixation element, the screw being positionedwithin the passageway and including a shank that defines a longitudinalaxis, the shank comprising a thread that directly engages a threadedportion of the inner surface, the fixation element being coupled to thescrew such that the fixation element is rotatable relative to the screwabout an axis that extends perpendicular to the longitudinal axis.
 35. Aspinal implant as recited in claim 34, wherein the inner surfaceincludes a threaded portion, the screw comprising a thread that directlyengages the threaded portion.
 36. A spinal implant as recited in claim34, wherein the body includes a channel that extends through the top andbottom surfaces, the channel comprising a first portion that is incommunication with the passageway and a second section that is spacedapart from the passageway by a wall that defines a threaded portion ofthe inner surface.
 37. A spinal implant as recited in claim 36, whereinthe body includes a second inner surface that defines a portion of thechannel, the second inner surface including a portion that extendstransverse to the longitudinal axis and is configured for engagementwith the fixation element.
 38. A spinal implant as recited in claim 34,wherein the body includes an opening that extends through the topsurface, the opening being in communication with the bay.
 39. A spinalimplant as recited in claim 38, wherein the opening is threaded andextends transverse to the longitudinal axis.
 40. A spinal implantcomprising: a body including opposite first and second surfaces andopposite top and bottom surfaces that each extend from the first surfaceto the second surface, the bottom surface being permanently fixedrelative to the top surface, the body including an inner surface thatdefines a passageway that extends through the top and bottom surfaces,the body further including a bay that extends into the first surface,the bay being spaced apart from the passageway by the inner surface, thebody including a channel that extends through the top and bottomsurfaces, the channel comprising a first portion that is incommunication with the passageway and a second section that is spacedapart from the passageway by a wall that defines a threaded portion ofthe inner surface; and a locking element comprising a screw and afixation element, the screw being positioned within the passageway andincluding a shank that defines a longitudinal axis, the shank comprisinga thread that directly engages a threaded portion of the inner surface,the fixation element being coupled to the screw such that the fixationelement is rotatable relative to the screw about an axis that extendsperpendicular to the longitudinal axis, wherein the body includes asecond inner surface that defines a portion of the channel, the secondinner surface including a portion that extends transverse to thelongitudinal axis and is configured for engagement with the fixationelement, and wherein the body includes an opening that extends throughthe top surface, the opening being in communication with the bay, theopening being threaded and extending transverse to the longitudinal axis